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184.1878 Thiamine mononitrate.

Home > Regulations > Direct food substances affirmed as generally recognized as safe > 184.1878 Thiamine mononitrate.



[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1878]

[Page 571-572]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 184_DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS 
SAFE--Table of Contents
 
        Subpart B_Listing of Specific Substances Affirmed as GRAS
 
Sec.  184.1878  Thiamine mononitrate.

    (a) Thiamine mononitrate 
(C12H17N5O4S, CAS Reg. No. 
532-43-4) is the mononitrate salt of thiamine. It occurs as white 
crystals or a white crystalline powder and is prepared from thiamine 
hydrochloride by dissolving the hydrochloride salt in alkaline solution 
followed by precipitation of the nitrate half-salt with a stoichiometric 
amount of nitric acid.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 325, which is incorporated by reference. Copies 
are available from the National Academy Press,

[[Page 572]]

2101 Constitution Ave. NW., Washington, DC 20418, or available for 
inspection at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal--register/code--of--
federal--regulations/ibr--locations.html.
    (c) In accordance with Sec.  184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a nutrient supplement as defined in 
Sec.  170.3(o)(20) of this chapter.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice. Thiamine mononitrate may be used in infant 
formula in accordance with section 412(g) of the Federal Food, Drug, and 
Cosmetic Act (the Act) or with regulations promulgated under section 
412(a)(2) of the Act.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[48 FR 55124, Dec. 9, 1983]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 184, Section 1878


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